Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

ikfe-CRO GmbH60 enrolled

Overview

The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.

* Phase IV * Indication: Diabetes mellitus Type 2 * Primary objective: To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period. \- Secondary objectives: To evaluate changes in the parameters * insulin, * glucose, * intact proinsulin (after a glucose challenge), * hsCRP, * adiponectin, * MMP-9, * HbA1c, * weight after 24 weeks of treatment. To investigate the changes of * glucose, * intact proinsulin, * hsCRP, * adiponectin, * HbA1c * weight between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks). To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates). -Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment) -Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment. * Weight * hsCRP * Adiponectin * MMP-9 * OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks * HOMA-IR score * HbA1c Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8: * Weight * hsCRP * Adiponectin * Fasting intact Proinsulin * Glucose * HbA1c * Safety Variables: * Adverse Events * Hypoglycaemic events Medication/Dosage: Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL) -Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months. Design: This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insulin-requiring Type 2 Diabetes Mellitus

Interventions

nph insulinDRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.

human insulinDRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. human insulin: bolus injections before each main meal

Insulin GlargineDRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Give written informed consent. * Patient consents that his/her family physician/diabetologist will be informed of trial participation * Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female) * Experienced in self blood glucose measurement for ≥ 3 months. * HbA1c ≤ 9% and \>6,5% * BMI \> 30 kg/m² * Age ≥ 18 years * Waist circumference \> 88 cm (female) and \> 102 cm (male) * NPH insulin treatment plus 1 or 2 OAD (except TZD) Exclusion Criteria: * History of drug or alcohol abuse within the last five years prior to screening * Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures * History of severe or multiple allergies * Treatment with any other investigational drug within 3 months prior to screening * Progressive fatal disease * History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dl in women and \>1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator * Pregnant or lactating women * Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner * Treatment with GLP1-analog or Thiazolidinediones (TZD) * hsCRP \> 10 mg/l (by rapid test at screening visit). * Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study * Type 1 Diabetes mellitus * Patients already treated with intensified conventional insulin therapy.

Locations (1)

ikfe GmbH

Mainz, Rhineland-Palatinate, Germany

RECRUITING

Outcomes

Primary Outcomes

Fasting Intact Proinsulin

The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.

Time frame: Change from baseline at 24 weeks